Daytime Nitetime

Description

This formulation contains a combination of active ingredients including Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Diphenhydramine Succinate, designed for multi-symptom relief of cold and flu symptoms. Acetaminophen serves as a pain reliever and fever reducer, while Dextromethorphan HBr acts as a cough suppressant. Phenylephrine HCl functions as a nasal decongestant, and Diphenhydramine Succinate provides antihistamine properties.

The product is available in softgel dosage forms, with packaging options of 32 softgels for daytime relief and 16 softgels for nighttime relief. This formulation is comparable to the active ingredients found in Vicks® DayQuil® and Vicks® NyQuil® Cold & Flu products.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours as needed.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not indicated for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is taken in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Rapid medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists for more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients are also advised to stop use and contact a healthcare professional if pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms develop, or if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, a persistent or chronic cough related to smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should seek advice from a doctor or pharmacist if they are taking sedatives or tranquilizers, or the blood-thinning medication warfarin.

Drug Interactions

The concomitant use of this product with warfarin, an anticoagulant, may elevate the risk of bleeding. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Additionally, the use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric disorders, or Parkinson’s disease. Patients should be advised to avoid this product during this period to prevent potential adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Nitetime (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

For dosing, adults and children aged 12 years and older may take 2 softgels with water every 6 hours for nighttime cold and flu relief, and every 4 hours for daytime cold and flu relief.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information for this medication. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned in the text. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential comorbidities. Regular monitoring may be warranted to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients must be advised against the concurrent use of other medications containing acetaminophen, as this can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily are at an increased risk of severe liver damage while using this product. Therefore, it is recommended that patients with compromised liver function limit their alcohol intake and consult with a healthcare professional regarding the safe use of acetaminophen. Regular monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

In cases of acetaminophen overdosage, significant health risks are associated with excessive intake.

Risk of Severe Liver Damage Administration of more than 4,000 mg of acetaminophen within a 24-hour period poses a substantial risk of severe liver damage. Healthcare professionals should be vigilant in assessing patients for potential overdosage, particularly in those who may inadvertently exceed this threshold.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen can lead to similar risks of severe liver damage. It is crucial for healthcare providers to review all medications a patient is taking to prevent unintentional overdosing.

Alcohol Consumption Considerations Patients who consume three or more alcoholic drinks daily while using acetaminophen are at an increased risk for severe liver damage. Healthcare professionals should counsel patients regarding the dangers of combining alcohol with acetaminophen and consider alternative pain management strategies for those with a history of alcohol use.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should initiate appropriate management protocols, which may include monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote in cases of significant overdosage. Prompt recognition and intervention are critical to mitigate the risk of severe hepatic injury.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs.

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been associated with acetaminophen use. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been reported, particularly in pediatric populations. Marked drowsiness is another noted effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Reports indicate that if pain or cough worsens or persists beyond 7 days, or if fever intensifies or lasts more than 3 days, medical evaluation should be sought. The presence of redness or swelling, the emergence of new symptoms, or the recurrence of cough accompanied by rash or headache that persists may indicate a serious underlying condition requiring further investigation.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 softgels with water every 6 hours for Nighttime Cold & Flu and every 4 hours for Daytime Cold & Flu. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Daytime Nitetime, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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